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FDA: New heart drug may cut hospitalizations

/ Source: The Associated Press

The Food and Drug Administration says an experimental drug from Sanofi-Aventis could significantly decrease hospitalizations caused by irregular heart rhythms.

Sanofi has asked the FDA to approve its drug Multaq to treat atrial fibrillation, a condition in which the upper chambers of the heart quiver instead of beating effectively, potentially causing blood clots.

On Wednesday an outside panel of cardiologists will give their opinion of the drug's safety and effectiveness. But regulators signaled Monday they already favor approval for the drug, also known as dronedarone, in briefing documents posted online.

The positive assessment marks a significant comeback from Multaq, which was rejected by FDA in 2006 after a study linked the medication to higher death rates.

But the head of FDA's heart drug division said more recent results from the company "define a population which derives benefit from dronedarone use and in whom safety was demonstrated."

The study that showed a higher death rate with Multaq included patients with severe heart failure, who already face higher mortality risks.

The same trial, which included more than 4,600 patients, also showed Multaq slightly reduced the risk of death, though the change was not significant. As a result, FDA heart division leader Abraham Karkowsky said he does not support a claim that the drug can reduce risk of death.

"The results are not convincing that, aside from hospitalization for atrial fibrillation, dronedarone prevents other morbid or mortal outcomes," Karkowsky wrote in his review.

Because of the negative results seen in earlier trials, Karkowsky recommended the drug be contraindicated in patients with severe heart failure.

On Wednesday, the FDA's panelists will weigh in that recommendation and others on who should receive the drug. The agency is not required to follow the group's advice, though it normally does.

If approved by the FDA, Multaq would be the first new medication in more than 25 years to treat atrial fibrillation. Currently doctors frequently prescribe the drug amiodarone, a heart rhythm medication marketed as Cordarone or Pacerone. But that drug can have significant side effects, including breathing problems.

The most frequent side effects reported with Multaq were diarrhea and other intestinal problems.

Paris-based Sanofi has touted the drug as a significant new franchise, with a potential market of more than 6 million patients in the U.S. and Europe, where the drug is also under review.

"Whereas other drugs may treat the symptoms of rate and rhythm, Multaq actually addresses the more important outcomes of hospitalization and death," said Dr. Paul Chew, president of Sanofi's U.S. research and development division.

Atrial fibrillation accounts for about 15 percent of strokes, according to the American Heart Association. And with the number of patients affected by the condition expected to double by 2050, several drugmakers are working on treatments.

Cardiome Pharma Corp. and partner Astellas Pharma currently have their own atrial fibrillation drug under review at the FDA. And earlier this month Bristol-Myers Squibb Co. licensed the rights to a comparable drug from two Japanese firms.